The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants with NASH. It will consist of 2 phases: * Randomized Double-Blind Phase * Open-Label Phase (optional)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
222
Change From Baseline in MQC on Liver Biopsy
Time frame: Baseline to Week 96
Event Free Survival (EFS) Using Kaplan-Meier
The EFS was the primary clinical efficacy endpoint and was assessed by the time to progression to cirrhosis. Participants were considered to have become cirrhotic if they had a post-baseline biopsy consistent with cirrhosis or developed overt signs and symptoms of cirrhosis. All overt signs and symptoms went through an adjudication process and were confirmed before they were considered for the EFS analysis.
Time frame: Baseline up to the time of progression to cirrhosis or last dose date (maximum: 240 weeks in the Blinded Phase), which ever occurred first
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Southern California Liver Centers
Coronado, California, United States
University of California, San Diego (UCSD)
San Diego, California, United States
University of California San Francisco (UCSF)
San Francisco, California, United States
University of Colorado
Aurora, Colorado, United States
Miami Veterans Administration Healthcare System
Miami, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Northwestern University
Chicago, Illinois, United States
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, United States
Iowa Digestive Disease Center
Clive, Iowa, United States
...and 58 more locations